Pfizer seeking FDA OK for COVID-19 vaccine booster dose
Last week, U.S. health officials announced plans to give COVID-19 booster shots to all Americans to shore up their protection amid the surging delta variant of the coronavirus.
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In emphatic vote, FDA panel rejects widespread Pfizer booster shots
Over several hours of discussion on Friday, members of the Food and Drug Administration panel of outside experts voiced frustration that Pfizer had provided little data on the safety of extra doses.
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After uproar over FDA’s handling of Biogen Alzheimer’s drug, Lilly presses on
Even as some drugmakers, including Indianapolis-based Eli Lilly and Co., are pushing to get experimental drugs approved, federal regulators are still dealing with a huge blowback over the controversial way they reviewed a new Alzheimer’s drug by rival Biogen.
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FDA panel rejects Pfizer/Lilly arthritis drug tanezumab as too risky
The expert panel for the Food and Drug Administration voted 19-1 that the drug’s modest benefits don’t outweigh its considerable risks, even with proposed measures to restrict who gets the medicine.
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Pfizer COVID-19 vaccine receives full approval from FDA
The U.S. becomes the first country to fully approve the shot, according to Pfizer, and CEO Albert Bourla said he hoped the decision “will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives.”
Extra COVID vaccine OK’d for those with weak immune systems
The late-night announcement by the Food and Drug Administration applies to several million Americans who are especially vulnerable because of organ transplants, certain cancers or other disorders.
UPDATE: Lilly to seek FDA approval for potential Alzheimer’s drug
Eli Lilly and Co. shares jumped more than 9% Thursday morning after it received “breakthrough therapy” designation for donanemab from the U.S. Food and Drug Administration, putting the drug on a path that could expedite its development.
FDA approves much-debated Alzheimer’s drug panned by experts
The decision, which could affect millions of older Americans and their families, also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.
FDA revives federal effort to ban menthol cigarettes
U.S. health regulators pledged again Thursday to try to ban menthol cigarettes, this time under pressure from African American groups to remove the mint flavor popular among Black smokers.
FDA weighs ban on menthol cigarettes, which disproportionately addict Black Americans
The FDA has long targeted menthol cigarettes for a regulatory crackdown amid warnings from doctors and other public health experts that the products are easier to start smoking, harder to quit and cause outsize harm to African Americans.
U.S. recommends ‘pause’ for J&J vaccine over clot reports
The CDC and FDA said Tuesday they were investigating clots in six women that occurred 6 to 13 days after vaccination.
New U.S. dietary guidelines: No candy, cake for children under 2
The guidelines stop short of two key recommendations from scientists advising the government. Those advisers said in July that everyone should limit their added sugar intake to less than 6% of calories and men should limit alcohol to one drink per day.
FDA tries to reassure public on safety of COVID-19 vaccine
FDA Commissioner Stephen Hahn denied Saturday that the White House had threatened his job if the agency didn’t move quickly on the vaccine.
FDA authorizes first COVID-19 vaccine in bid to end surging pandemic
The U.S. gave the final go-ahead Friday to the nation’s first COVID-19 vaccine, marking what could be the beginning of the end of an outbreak that has killed nearly 300,000 Americans.
FDA allows first rapid COVID-19 test that gives results at home
The announcement by the Food and Drug Administration represents an important step in U.S. efforts to expand testing options for COVID-19. However, the test will require a prescription, likely limiting its initial use.
White House nixes tougher FDA guidelines on vaccine approval
FDA Commissioner Stephen Hahn has pledged that career scientists, not politicians, will decide whether any coronavirus vaccine meets clearly stated standards that it works and is safe.
FDA says at least 75 brands of hand sanitizers may be toxic
The FDA also advises Americans to be wary of products that claim to be “FDA-approved,” as none exist, or say they provide protection for “up to 24 hours.”
Government to propose banning flavors used in e-cigarettes
President Donald Trump said Wednesday his administration will propose banning thousands of flavors used in e-cigarettes to combat a recent surge in underage vaping.
FDA warns top marijuana company for making CBD health claims
CVS Health, which started carrying CBD skin products in some states this year, plans to remove Curaleaf products from its shelves following the FDA’s warning.
Lilly’s push into pain research starting to pay off
In recent months, the drugmaker has won federal approval to sell a drug called Emgality for two conditions: migraine pain and cluster headaches.
Trump orders simpler path for genetically engineered food
The move comes as companies are turning to newer genetic engineering techniques that make it easier to tinker with the traits of plants and animals.
Food regulators pushing for clarity on expiration dates
By clarifying terms such as “Sell by” and “Use by,” U.S. regulators are trying to prevent people from prematurely tossing products and to reduce the mountains of food that goes to waste each year.
Ex-employees to testify exec knew drugs were dangerous
Paul Elmer, who founded Pharmakon 16 years ago and shut it down three years ago, faces charges of adulterating compounded drugs, conspiracy and obstructing a U.S. FDA investigation.